Re: Re: Message from Senator Blanche Lincoln

[Guest guest]

That's me and that sure is the truth.

Lynda

At 02:09 PM 7/21/2005, you wrote:

>Very interesting ... thanks Rogene.

>

>Unfortunately ... women who receive implants post mastectomy fare

>even worse than augmented women ...

>

>

>

> > Dear Rogene:

> >

> > Thank you for contacting me about the use of silicone

> > gel breast implants.

> >

> > The Food and Drug Administration (FDA) has regulated

> > breast implants as medical devices since 1976. Due to

> > health concerns in recent years, the FDA has allowed

> > silicone gel implants to be used only in women who

> > have had mastectomies.

> >

> > The use of breast implants is not without potential

> > hazards. In 2000, a National Cancer Institute study

> > reported a failure rate of 55% per implant in women

> > who have had implants for an average of 16 years. As

> > you know, on October 15, 2003, an advisory panel to

> > the Food and Drug Administration (FDA), voted nine to

> > six to allow for the moratorium to be lifted despite

> > the fact that data still showed long-term consequences

> > and complications with silicone gel implants.

> >

> > In December 2003, I and several of my Senate

> > colleagues sent a letter to FDA Commissioner Mark

> > McClellan to delay a formal decision on silicone

> > breast implants until all relevant data was made

> > available and considered.

> >

> > Soon after, the FDA issued a " not approvable " letter

> > for Inamed Corporation, a leading provider of silicone

> > breast implant devices. Since then, Inamed Corporation

> > and their competitor Mentor Corporation have filed

> > applications for approval with the FDA.

> >

> > In April of 2005, the FDA's General and Plastic

> > Surgery Devices advisory panel voted against

> > recommending approval of Inamed Corporations's

> > silicone gel implants and voted to recommend approval

> > of Mentor Corporations silicone gel implants.

> >

> > This occurred despite the fact that FDA scientists

> > found that both companies failed to respond

> > sufficiently to questions regarding the long-term

> > safety of their products.

> >

> > I am concerned about the split decision by the FDA's

> > advisory panel because questions remain regarding the

> > safety of the implants produced by both Mentor and

> > Inamed. I believe the FDA's recent recommendations

> > appear inconsistent, despite similar findings on

> > safety.

> >

> > For both Inamed and Mentor's devices, I have concerns

> > that both companies are unable to project long-term

> > failure rates.

> >

> > You will be pleased to know that I, along with several

> > of my female colleges in the Senate have sent a letter

> > to Lester Crawford, Acting Commissioner of the FDA,

> > stating our concern over the safety of silicone breast

> > implants, specifically regarding the FDA's recent

> > split decision.

> >

> > We are asking the FDA to note a distinction between

> > the use of implants for reconstruction and

> > augmentation.

> >

> > Again, thank you for sharing your concerns. Please do

> > not hesitate to let me know whenever I may be of

> > assistance to you in the future.

> >

> > Sincerely,

> >

> > Blanche L. Lincoln BLL/dh

>

>

>

>

>

>Opinions expressed are NOT meant to take the place of advice given by

>licensed health care professionals. Consult your physician or licensed

>health care professional before commencing any medical treatment.

>

> " Do not let either the medical authorities or the politicians mislead you.

>Find out what the facts are, and make your own decisions about how to live

>a happy life and how to work for a better world. " - Linus ing,

>two-time Nobel Prize Winner (1954, Chemistry; 1963, Peace)

>

>